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SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

Sponsor
The University of Hong Kong (Other)
Overall Status
Unknown status
CT.gov ID
NCT03950102
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
54
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.

Condition or Disease Intervention/Treatment Phase
  • Radiation: SBRT
 N/A

Detailed Description

The study population includes patients 18 years of age or older with HCC, who are accepted on waiting list for deceased donor liver transplantation (DDLT).

Patient will be assessed in a multidisciplinary committee and they will receive SBRT unless otherwise contraindicated. Patients will undergo SBRT under standard protocol.

Patients with HCC beyond University of California, San Francisco criteria (UCSF) will be removed from waitlist.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation
Actual Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Jun 30, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: SBRT

SBRT will be used as the primary bridging therapy for HCC patients on waitlist

Radiation: SBRT
Radiation dose of 27.5-50Gy in 5 fractions over 5-14 days with a radical dose as high as achievable based on mean liver dose (MLD), while fulfilling the dose constraints of OARs

Outcome Measures

Primary Outcome Measures

  1. Risk of classical radiation induced liver disease (RILD) after SBRT [From time of SBRT to 3 months afterwards]

    Defined as elevated liver transaminases >5 times of upper normal limit or worsening of Child's score by >2 within 3 months after SBRT

  2. Rate of transplant complication [From time of transplant to 1 months afterwards]

    Perioperative complication will be assessed according to Clavien-Dindo classification

Secondary Outcome Measures

  1. Rate of dropout from transplant waitlist [From time of enrolment to up to 2 years]

    All HCC patients on waitlist will be assessed regularly and will be removed from waitlist if HCC stage is beyond UCSF criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Radiological diagnosis of HCC confirmed according to AASLD criteria

  2. All patients who are accepted on deceased donor waiting list

  3. HCC within UCSF criteria (defined as solitary tumor <=6.5cm OR up to 3 tumors <=4.5cm, total sum <=8cm)

Exclusion Criteria:

  1. age <18 year old;

  2. Child's C cirrhosis;

  3. Eastern Cooperative Oncology Group (ECOG) score >2;

  4. presence of extrahepatic metastasis;

  5. radiological tumor invasion to portal, hepatic vein or its branches;

  6. absolute contraindications to RT (e.g. previous RT to liver);

  7. positive pregnancy test;

  8. unwilling or unable to adhere to study requirements and procedure;

  9. any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Mary Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Tiffany Wong, MBChB, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Tiffany Cho-Lam Wong, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03950102
Other Study ID Numbers:
  • UW15-191
First Posted:
May 15, 2019
Last Update Posted:
May 28, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of May 28, 2019